Cresemba (Intravenous)

Isavuconazonium injection is used to treat serious fungal or yeast infections, including invasive aspergillosis and invasive mucormycosis. This medicine works by killing the fungus or yeast and stopping its growth.

This medicine is to be given only by your doctor or under their direct supervision.

It is important for your doctor to check how you are doing after treatment. This is to ensure that the infection is completely gone and to allow your doctor to look for any unwanted effects. Blood tests may be needed to check for unwanted effects.

Do not use this medicine with carbamazepine (Tegretol®), ketoconazole (Nizoral®), phenobarbital (Luminal®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), or St. John's wort. Using these medicines together may cause unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to avoid getting pregnant during treatment and for at least 28 days after the last dose of this medicine. If you think you might be pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be signs of a serious liver problem.

This medicine may cause a serious allergic reaction called infusion related reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have chills, dizziness, trouble breathing, chest tightness, numbness or tingling, change in sense of touch, or lightheadedness or faintness while you are receiving this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions (eg, Stevens-Johnson syndrome) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to understand how isavuconazonium injection affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of isavuconazonium injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines can be used together, but your doctor may need to adjust the dose or take other precautions. When you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir
• Boceprevir
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Delavirdine
• Enzalutamide
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lumacaftor
• Mephobarbital
• Mitotane
• Nefazodone
• Nelfinavir
• Phenytoin
• Posaconazole
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Atorvastatin
• Cyclosporine
• Digoxin
• Fluconazole
• Lopinavir
• Mavacamten
• Midazolam
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nirmatrelvir
• Quinidine
• Sirolimus
• Tacrolimus
• Tocilizumab

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Bupropion

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following is not recommended. Your doctor may choose not to treat you with this medication, change some of the other medicines you take, or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Heart rhythm problem (e.g., familial short QT syndrome)—Should not be used in patients with this condition.

• Liver disease—Use with caution. It may worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody urine
• Blurred vision
• Chest pain or tightness
• Confusion
• Decreased frequency or amount of urine
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast or irregular heartbeat
• Loss of appetite
• Lower back or side pain
• Muscle pain or cramps
• Muscle spasms (tetany) or twitching
• Numbness or tingling in the hands, feet, or lips
• Seizures
• Severe nausea or vomiting
• Sweating
• Tingling of the hands or feet
• Trembling
• Trouble breathing
• Unusual tiredness or weakness

Less common or rare

• Black, tarry stools
• Chills
• Cough or hoarseness
• Dark urine
• Fever with or without chills
• Hives, itching, or rash
• Irritation
• Joint pain, stiffness, or swelling
• Light-colored stools
• Painful or difficult urination
• Red, swollen skin
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stomach pain
• Unusual bleeding or bruising
• Upper right abdominal or stomach pain
• Yellow eyes and skin

Incidence not known

• Blistering, peeling, or loosening of the skin
• Diarrhea
• Red skin lesions, often with a purple center
• Red, irritated eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• Anxiety
• Back pain
• Headache
• Heartburn or indigestion
• Seeing, hearing, or feeling things that are not there
• Trouble sleeping
• Unusual excitement, nervousness, or restlessness

Less common or rare

• Burning, numbness, tingling, or painful sensations
• Continuing ringing or buzzing or other unexplained noise in the ears
• Decreased vision
• Eye pain
• Feeling of constant movement of self or surroundings
• Hearing loss
• Loss or thinning of the hair
• Sensation of spinning
• Unsteadiness or awkwardness
• Weakness in arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cresemba

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antifungal

Chemical Class: Isavuconazonium

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 1 hour.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.